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Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices 57935

Controlled substance Schedule

Allylprodine (9602) ...... I Alphacetylmethadol except levo-alphacetylmethadol (9603) ...... I Alphameprodine (9604) ...... I Alphamethadol (9605) ...... I Betacetylmethadol (9607) ...... I Betameprodine (9608) ...... I Betamethadol (9609) ...... I Betaprodine (9611) ...... I (9613) ...... I (9622) ...... I Hydroxypethidine (9627) ...... I Noracymethadol (9633) ...... I Norlevorphanol (9634) ...... I Normethadone (9635) ...... I Racemoramide (9645) ...... I Trimeperidine (9646) ...... I 1-Methyl-4-phenyl-4-propionoxypiperidine (9661) ...... I (9750) ...... I Para-Fluorofentanyl (9812) ...... I 3-Methylfentanyl (9813) ...... I Alpha-methylfentanyl (9814) ...... I Acetyl-alpha-methylfentanyl (9815) ...... I Beta-hydroxyfentanyl (9830) ...... I Beta-hydroxy-3-methylfentanyl (9831) ...... I Alpha-methylthiofentanyl (9832) ...... I 3-Methylthiofentanyl (9833) ...... I Thiofentanyl (9835) ...... I Methamphetamine (1105) ...... II Methylphenidate (1724) ...... II Amobarbital (2125) ...... II Pentobarbital (2270) ...... II Secobarbital (2315) ...... II Glutethimide (2550) ...... II Nabilone (7379) ...... II 1-Phenylcyclohexylamine (7460) ...... II (7471) ...... II Phenylacetone (8501) ...... II 1-Piperidinocyclohexanecarbonitrile (8603) ...... II Alphaprodine (9010) ...... II (9120) ...... II Ecgonine (9180) ...... II (9190) ...... II (9210) ...... II (9220) ...... II Meperidine (9230) ...... II , bulk (non-dosage forms) (9273) ...... II Levo-alphacetylmethadol (9648) ...... II Noroxymorphone (9668) ...... II Racemethorphan (9732) ...... II (9737) ...... II (9739) ...... II (9740) ...... II (9743) ...... II (9780) ...... II

The company plans to import small activity for this drug code is authorized DEPARTMENT OF JUSTICE quantities of the listed controlled for this registration. substances for the manufacture of Drug Enforcement Administration Louis J. Milione, analytical reference standards and distribution to their research and Deputy Assistant Administrator. [Docket No. DEA–392] [FR Doc. 2016–20237 Filed 8–23–16; 8:45 am] forensic customers. Placement of these Importer of Controlled Substances drug codes onto the company’s BILLING CODE 4410–09–P Application: Akorn, Inc. registration does not translate into automatic approval of subsequent ACTION: Notice of application. permit applications to import controlled substances. DATES: Registered bulk manufacturers of In reference to drug code 7360 the affected basic class, and applicants therefore, may file written comments on (Marihuana) the company plans to or objections to the issuance of the import a synthetic . No other proposed registration in accordance

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with 21 CFR 1301.34(a) on or before DEPARTMENT OF JUSTICE drug codes are authorized for this September 23, 2016. Such persons may registration. Drug Enforcement Administration also file a written request for a hearing Louis J. Milione, on the application pursuant to 21 CFR [Docket No. DEA–392] Deputy Assistant Administrator. 1301.43 on or before September 23, [FR Doc. 2016–20235 Filed 8–23–16; 8:45 am] 2016. Bulk Manufacturer of Controlled Substances Application: Noramco, Inc. BILLING CODE 4410–09–P ADDRESSES: Written comments should be sent to: Drug Enforcement ACTION: Notice of application. Administration, Attention: DEA Federal DEPARTMENT OF JUSTICE DATES: Registered bulk manufacturers of Register Representative/ODW, 8701 Notice of Lodging of Proposed Morrissette Drive, Springfield, Virginia the affected basic classes, and applicants therefore, may file written Consent Decree Under the Clean Air 22152. All requests for hearing must be comments on or objections to the Act sent to: Drug Enforcement issuance of the proposed registration in Administration, Attn: Administrator, On August 18, 2016, the Department accordance with 21 CFR 1301.33(a) on of Justice lodged a proposed Consent 8701 Morrissette Drive, Springfield, or before October 24, 2016. Virginia 22152. All requests for hearing Decree with the United States District ADDRESSES: Written comments should Court for the District of Columbia in the should also be sent to: (1) Drug be sent to: Drug Enforcement Enforcement Administration, Attn: lawsuit entitled United States v. Harley- Administration, Attention: DEA Federal Davidson, Inc., et al., Civil Action No. Hearing Clerk/LJ, 8701 Morrissette Register Representative/ODW, 8701 Drive, Springfield, Virginia 22152; and 1:16–cv–01687. Morrissette Drive, Springfield, Virginia The United States’ Complaint alleges (2) Drug Enforcement Administration, 22152. Attn: DEA Federal Register that Harley-Davidson, Inc. (and three SUPPLEMENTARY INFORMATION: The Representative/ODW, 8701 Morrissette related companies) manufactured and Attorney General has delegated her sold over 339,392 after-market devices Drive, Springfield, Virginia 22152. authority under the Controlled (known as ‘‘Super Tuners’’ and used SUPPLEMENTARY INFORMATION: Substances Act to the Administrator of with Harley-Davidson motorcycles) in The Attorney General has delegated the Drug Enforcement Administration violation of the Clean Air Act her authority under the Controlled (DEA), 28 CFR 0.100(b). Authority to prohibition on the manufacture or sale Substances Act to the Administrator of exercise all necessary functions with of devices that defeat the functioning of respect to the promulgation and the Drug Enforcement Administration the motorcycle’s certified emissions implementation of 21 CFR part 1301, control system. The Complaint also (DEA), 28 CFR 0.100(b). Authority to incident to the registration of alleges, relatedly, that Defendants exercise all necessary functions with manufacturers, distributors, dispensers, violated the provision of the Act that respect to the promulgation and importers, and exporters of controlled prohibits any person from removing or implementation of 21 CFR part 1301, substances (other than final orders in rendering inoperative a motor vehicle’s incident to the registration of connection with suspension, denial, or certified emissions control system and manufacturers, distributors, dispensers, revocation of registration) has been from causing such ‘‘tampering.’’ Finally, importers, and exporters of controlled redelegated to the Deputy Assistant the Complaint alleges that Defendants substances (other than final orders in Administrator of the DEA Office of manufactured and sold more than connection with suspension, denial, or Diversion Control (‘‘Deputy Assistant 12,000 motorcycles from model years revocation of registration) has been Administrator’’) pursuant to section 7 of 2006, 2007 and 2008 that were not redelegated to the Deputy Assistant 28 CFR part 0, appendix to subpart R. certified by EPA as required by the Administrator of the DEA Office of In accordance with 21 CFR Clean Air Act. Diversion Control (‘‘Deputy Assistant 1301.33(a), this is notice that on July 20, The Consent Decree requires Administrator’’) pursuant to section 7 of 2016, Noramco, Inc., 1440 Olympic Defendants to stop selling the illegal 28 CFR part 0, appendix to subpart R. Drive, Athens, Georgia 30601 applied to tuners in the United States by August be registered as a bulk manufacturer the In accordance with 21 CFR 23, 2016. Defendants will also offer to following basic classes of controlled 1301.34(a), this is notice that on June 3, buy back all such tuners in stock at substances: 2016, Akorn, Inc., 1222 W. Grand Harley-Davidson dealerships across the Avenue, Decatur, Illinois 62522 applied country and destroy them. The Decree requires Defendants to obtain an to be registered as an importer of Controlled substance Schedule Executive order from the California Air remifentanil (9739), a basic class of Resources Board (CARB) for any tuners controlled substances listed in schedule Marihuana (7360) ...... I it sells in the United States in the future. II. (7370) ..... I (9301) ...... I These Executive orders (E.O.s) will The company plans to import Nabilone (7379) ...... II demonstrate that the CARB-certified remifentanil in dosage form for tuners do not cause Defendants’ distribution. motorcycles to exceed the EPA-certified The company plans to manufacture emissions limits. Defendants must also Louis J. Milione, bulk active pharmaceutical ingredients conduct tests on motorcycles that have Deputy Assistant Administrator. (APIs) and reference standards for been tuned with the E.O.-certified [FR Doc. 2016–20236 Filed 8–23–16; 8:45 am] distribution to their customers. tuners and provide the results to EPA to BILLING CODE 4410–09–P In reference to drug codes 7360 ensure that their motorcycles remain in (marihuana) and 7370 compliance with EPA emissions (tetrahydrocannabinols), the company requirements. In addition, for any plans to bulk manufacturer these drugs uncertified Super Tuners that as synthetic. No other activities for these Defendants sell outside the United

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